NACDS and NCPA speak out at FDA hearing in favor of BTC classification

WASHINGTON Both the National Association of Chain Drug Stores and the National Community Pharmacists Association are heavily in favor of the creation of a third class of drugs, according to testimony provided by both associations before a Food and Drug Administration panel on the matter here this afternoon, provided that the increased pharmacist-patient interaction a behind-the-counter class of drugs would generate would be duly compensated.

NCPA president Stephen Giroux suggested three reasons behind retail pharmacy’s strong support of a BTC class of drugs—reduced health costs, increased consumer convenience and the potential utilization of BTC as a vehicle in creating a comprehensive post-marketing tool with pharmacist oversight. “Not only are pharmacists the most accessible healthcare provider [out there], pharmacists have the training and the knowledge to [provide drug] interactions,” he said.

“Pharmacists are uniquely qualified to take on this new role,” testified NACDS’ Mary Ann Wagner, but if an appropriate reimbursement model is not included in that new rule, a BTC class of drugs could evolve into a medicine class that limits access to consumers, and similarly has the potential to increase healthcare costs.

As for concerns raised earlier in the day pertaining to the potential draining a BTC class of drugs would have on pharmacy workflow (see “FDA panel hears arguments in BTC debate“), Giroux suggested pharmacists would take that new challenge in stride. And pharmacists may not have a problem accessing comprehensive patient records, Giroux said, especially as e-prescribing capabilities continue to evolve through association backed partnerships such as SureScripts.

Wagner suggested that a BTC class of drugs not be used as a reverse-switch option. “This class should not be used to enforce age” or any other restrictions, she said. The recently legislated migration of pseudoephedrine to behind the pharmacy counter could serve as an example of an inappropriate use of a BTC model—PSE was first BTC because of concerns over diversion, not concerns over product safety.

Likewise, Wagner opined that the BTC class of drugs should not be a layover for a prescription medicine en route to over-the-counter status. Rather, it should be a permanent class of drugs because of the necessity of pharmacist intervention.

Giroux, however, suggested that BTC might indeed become a new waypoint for drug switching from Rx-to-OTC, and appropriately so.

And while Wagner acknowledged that the FDA had little to do by way of establishing a reimbursement-based business model around the proposed BTC class of drugs, that issue could very well be the most crucial question for pharmacy operators. It is possible, she said, that moving drugs from prescription-only to BTC could prompt maintenance care operators to drop those medicines from their drug formularies. “The additional clinical role [of the pharmacist] must be recognized and compensated,” she said.

Liability is another concern for drug store operators, Wagner said, noting that product liability in a BTC model should not necessarily pass from manufacturer to retailer.

WASHINGTON The Council for Responsible Nutrition on Tuesday released the results of its “Life…supplemented” Healthcare Professionals Impact Study, finding that more than three quarters of U.S. physicians (79 percent) and nurses (82 percent) recommend dietary supplements to their patients. The study also found that an almost equal number—72 percent of physicians and 89 percent of nurses—personally use vitamin, mineral herbal and other supplements either regularly, occasionally or seasonally, which is a higher percentage than the 68 percent of adults who report they take nutritional or dietary supplements, the Council noted.

“This survey, which is a first for our industry, shows that healthcare professionals believe that dietary supplements are part of a healthy lifestyle,” stated Steve Mister, president and chief executive officer of CRN. “Not only are they taking supplements for their own benefit, but they’re also recommending them to their patients. The approval of our products from reputable, respectable healthcare professionals, such as doctors and nurses, should be encouraging to consumers who already incorporate supplements into their wellness routine, and a wake-up call to those who haven’t yet started to do so.”

Of the 72 percent of physicians who use supplements, 85 percent also recommend them to their patients; and of the 28 percent of physicians who do not use supplements, three out of five (62 percent) still recommend them.

“It is common sense that physicians who personally take supplements also recommend them to their patients,” stated Donnica Moore, president of the Sapphire Women’s Health Group and a member of the study’s physician advisor team. “It’s interesting that the majority of physicians who don’t use supplements still recognize their patients may benefit from them. Although the study doesn’t provide an explanation, it may simply be that physicians recommend supplements to their patients for specific conditions that don’t apply to the physician’s own personal health.”

The number of physicians recommending dietary supplements to their patients is highest among obstetrician/gynecologists (91 percent), followed by primary care physicians (84 percent). Primary care physicians, OB/GYNs and nurses recommend supplements as often for “general well-being/prevention” as they do for special conditions, while other specialists recommend supplements more often for special conditions.

Almost three quarters of physicians (72 percent) and even more nurses (87 percent) reported they personally ask their patients about their use of dietary supplements. Also, 40 percent of physicians and 43 percent of nurses report that when discussing supplements with their patients, they, not their patients, are the ones who bring up the subject most often.

“Our industry needs to continue this type of research,” noted Judy Blatman, vice president, communications, CRN. “It’s important that we use this as benchmark data, continuing to do these types of surveys to see what trends develop in the upcoming years. … Healthcare professionals are an important audience for our industry and for our consumers and we must continue to be proactive in this area.”

Diabetes is focus of Indiana, Nevada initiatives

INDIANAPOLIS and LAS VEGAS Eli Lilly and the Indiana Health Industry Forum will hold a summit on Nov. 13 called, “Building on Indiana’s Strength in Diabetes Research, Diagnostics, and Therapeutics,” to focus on the development of better therapies and diagnostic technologies for the prevention and management of diabetes.

The IHIF is a not-for-profit organization that works to define factors that can lead to economic development success in healthcare for Indiana and then build programs that support the future of the industry in the state.

The summit will be used to connect Indiana resources for the development of diabetes treatments and diagnostics, as well as identify business collaborations. In addition to attendees from academia and pharmaceutical and biotechnology industries, representatives from Indiana state government, venture capital concerns, clinical research organizations, research service companies and advocacy groups will attend.

Also, today in Nevada, Health Innovations, the Nevada Health Care Coalition and Sanofi-Aventis released a new report on the demographics, costs and quality of care for people with Type 2 diabetes.

The Nevada Type 2 Diabetes Report for 2007 gives an overview of patient demographics, hospital and provider charges, and utilization of clinical services and drug therapy for people with Type 2 Diabetes in key local markets in the state of Nevada. The report also provides benchmarks from Phoenix as well as national benchmarks that can help employers and providers better identify opportunities to serve the needs of people with Type 2 diabetes.

Schnucks said that using Rochester, N.Y.-based PharmaSmart’s technology would help drive Medicare Star Ratings objectives, including adherence for hypertension and blood pressure control, both of which are triple-weighted measures that national and regional insurers focus on.

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